UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035681 |
|---|---|
| Receipt number | R000040645 |
| Scientific Title | The Usefulness of Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures in Advanced Chronic Pancreatitis |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2019/08/10 03:42:33 |
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Basic information
Public title
The Usefulness of Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures in Advanced Chronic Pancreatitis
Acronym
Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures
Scientific Title
The Usefulness of Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures in Advanced Chronic Pancreatitis
Scientific Title:Acronym
Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures
Region
| Asia(except Japan) |
Condition
Condition
To evaluate the usefulness of non-flared short fully covered self-expandable metallic stent (FCSEMS) that was designed to minimize ductal injury and migration for refractory pancreatic stricture in advanced chronic pancreatitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of non-flared short fully covered self-expandable metallic stent (FCSEMS) that was designed to minimize ductal injury and migration for refractory pancreatic stricture in advanced chronic pancreatitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resolution of stricture
: complete runoff of contrast material was observed and an inflated extraction balloon could be passed through the pancreatic duct without resistance.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Endoscopic stenting for pancreatic duct stricture using BONASTENT M-Intraductal stent
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Symptomatic benign pancreatic duct strictures
2) Initially treated with pancreatic sphincterotomy and 1-2 plastic stent (PS) insertion
3) Recurrent painful stricture after initial stricture resolution or persistent stricture despite PS(s)
Key exclusion criteria
1) Evidence of pancreatic neoplasia on CT scan and/or EUS
2) Multiple pancreatic ductal strictures
3) Proximal pancreatic ductal strictures
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Jong Ho |
| Middle name | |
| Last name | Moon |
Organization
SoonChunHyang University Hospital
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
14584
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 14584, Korea
TEL
+82-32-621-5094
jhmoon@schmc.ac.kr
Public contact
Name of contact person
| 1st name | Yun Nah |
| Middle name | |
| Last name | Lee |
Organization
SoonChunHyang University Hospital
Division name
Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
14584
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL
+82-32-621-5094
Homepage URL
yunnah@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University Research Fund
Institute
Department
Personal name
Funding Source
Organization
SoonChunHyang University Research Fund
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Soonchunhyang bucheon hospital
Address
Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 14584, Korea
Tel
+82326216363
irb@schmc.ac.kr
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 26 | Day |
Last modified on
| 2019 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040645
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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